Clearance Summary
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors received FDA 510(k) clearance under submission number K223114, sponsored by Gm Dos Reis Industria E Comerico Ltda.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-08-02.
- Submission: K223114
- Applicant / Sponsor: Gm Dos Reis Industria E Comerico Ltda.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2023-08-02
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.